Dexcom G4 Platinum, First FDA Approved CGM for Children Aged 2-17

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Dexcom G4 PlatinumThe U.S. FDA has approved the expanded use of the Dexcom G4 Platinum Continuous Glucose Monitoring System for patients with diabetes ages 2 to 17 years. And Dexcom G4 PLATINUM (Pediatric) is the first CGM device approved for persons with diabetes in the 2-6 age-range and the only CGM device that offers an alternate sensor wear site on the upper buttocks for added flexibility.

The previously approved G4 Platinum System is for insertion of the sensor in the abdomen only. The new Dexcom G4 Platinum (Pediatric) System includes the upper buttock in addition to the abdomen as sensor insertion sites.

The device system components (sensor and transmitter) are unmodified from the previous system.

Before the approval, the FDA reviewed data from a pivotal clinical study of in-clinic and home-use patients to assess the accuracy and precision of the system. One hundred and seventy-six patients ages 2 to 17 wore the G4 Platinum (Pediatric) sensor for seven days (168 hours). The accuracy of the system’s glucose readings was evaluated by comparing them to a clinical laboratory reference method (for patients ages 6 to 17) and to results obtained from finger stick samples on a blood glucose meter (for patients ages 2 to 17) 

The pivotal clinical study demonstrated that the G4 Platinum (Pediatric) System performance in pediatric subjects was not as accurate as the performance of the same device in adults. In addition, the performance of the hypoglycemic detection alert in the pediatric study was poor relative to that seen in the adult study, particularly at blood glucose concentrations below 70 milligrams per deciliter of blood. Despite these limitations, the study did demonstrate that the device is effective for tracking and trending to determine patterns in glucose levels, and for alerting patients when glucose values are approaching potentially dangerously high (hyperglycemic) and/or dangerously low (hypoglycemic) levels.

To communicate the reduced accuracy in pediatric patients to users, two warnings are included in the labeling, and are displayed on the receiver screen when a new sensor session is started or the alert thresholds are changed:

  • In a pediatric clinical study, larger differences were observed between this CGM device and actual blood glucose values compared to those differences observed in the adult clinical study. Use your blood glucose meter for treatment decisions.
  • In a pediatric clinical study, a significant number of low glucose events were not detected by CGM. Do not rely solely on CGM alerts to detect low glucose.

Research on CGMs is underway as part of a developmental artificial pancreas device system (APDS) for people with type 1 diabetes, a device that includes a CGM and an insulin pump. An artificial pancreas system would monitor glucose levels and automatically pump the appropriate amount of insulin as determined by a computer algorithm.

 

 

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